Clinical evaluations clinical investigations under the amended Medical Device Directive.
Directive 2007/47/EC1 amends the earlier Medical Device and Active Implantable Medical Device Directives. Amongst its new requirements is the need for more clinical data and more frequent clinical investigations in the conformity assessment of innnovative medical devices. Details of the changes and the implications for manufacturers are outlined.
Dannhorn
Dieter R
DR
Mdt medical device testing GmbH, Ochsenhausen, Germany. dieter.dannhorn@mdt-gmbh.com
Schwabedissen
Heidrun
H
D002986:Clinical Trials as Topic / Q000592:standards*; D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D033161:Government Regulation; D019983:Guideline Adherence; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*